- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical... Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data and Identify and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset ... dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… more
- Tris Pharma (Monmouth Junction, NJ)
- …portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory, and commercial scenarios Prepare clear and concise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... including experience in one or more key functions (eg, clinical research, clinical operations, data management, biostatistics, project management) required-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (Rahway, NJ)
- …standards.It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with ... and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable...include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Lundbeck (New York, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the...Ability to use digital tools and apply customer and data -based insights to build opportunities, develop strategy & tactics… more
